Team-Based Learning Integrated Into Clinical Simulation in Nursing Students (TBLab)

Effectiveness of Team-Based Learning Integrated Into Clinical Simulation in Nursing Education: A Randomized Controlled Trial (TBLab)

This study aims to evaluate whether integrating Team-Based Learning (TBL) into clinical simulation improves learning outcomes in undergraduate nursing students compared with traditional simulation alone.

Team-Based Learning (TBL) is an educational approach that actively involves students in small groups through individual preparation, teamwork, and application of knowledge to real-world problems. Clinical simulation is already widely used in nursing education to help students practice technical and non-technical skills in a safe environment. Combining these two approaches may enhance learning, but evidence is still limited.

In this randomized controlled trial, third-year nursing students enrolled in the Bachelor of Nursing program at the University of Pisa will be randomly assigned to one of two groups. One group will receive a Team-Based Learning session before participating in a clinical simulation, while the control group will take part in standard simulation activities without TBL.

The study will assess students' knowledge, technical skills, and teamwork competencies immediately after the educational activities and again at three and six months to evaluate retention of learning outcomes. Participation is voluntary and does not involve additional risks beyond standard educational activities.

Study Overview

• Status: Not yet recruiting
• Conditions: Nursing Education
• Intervention / Treatment: Behavioral: Team-Based Learning Integrated Clinical Simulation; Behavioral: Traditional Clinical Simulation

Detailed Description

This study is a single-center randomized controlled trial designed to evaluate the effectiveness of integrating Team-Based Learning (TBL) into clinical simulation activities in undergraduate nursing education. The trial will be conducted within the Bachelor of Nursing program at the University of Pisa and will involve third-year nursing students participating in curricular simulation-based training.

Participants who provide informed consent will be randomly assigned in a 1:1 ratio to either an experimental group or a control group. The experimental group will receive a structured Team-Based Learning intervention prior to the clinical simulation session. This intervention includes individual preparation using evidence-based learning materials, an Individual Readiness Assurance Test (I-RAT), a Team Readiness Assurance Test (T-RAT), team-based application activities, and structured feedback and debriefing.

The control group will participate in standard clinical simulation activities according to the existing undergraduate nursing curriculum, without integration of the Team-Based Learning methodology. All simulation activities focus on tracheobronchial suctioning through a tracheostomy tube, a complex nursing procedure requiring integration of theoretical knowledge, technical skills, and teamwork competencies.

Outcome measures include knowledge acquisition, technical skill performance assessed through a structured checklist, and teamwork competencies measured using validated instruments. Assessments will be conducted immediately after the intervention (T0) and at follow-up time points of three months (T1) and six months (T2) to evaluate both immediate learning effects and retention over time.

The study is embedded within routine educational activities and is classified as minimal risk. No clinical interventions are involved, and participation or non-participation does not affect students' academic evaluation or progression. Results will contribute to the evidence base on innovative educational strategies in nursing education and support the development of effective, evidence-informed teaching practices.

• Study Type: Interventional
• Enrollment (Estimated): 150
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Nicola Pagnucci, RN, MSN, PhD; Phone Number: +393472483475; Email: nicola.pagnucci@unipi.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Enrollment in the third year of the Bachelor of Nursing program at the University of Pisa.
• Participation in scheduled clinical simulation activities as part of the undergraduate nursing curriculum.
• Provision of written informed consent to participate in the study

Exclusion Criteria:

• None

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental; Team-Based Learning Integrated Simulation	Behavioral: Team-Based Learning Integrated Clinical Simulation; Participants receive a structured educational intervention integrating Team-Based Learning into a clinical simulation session. The intervention includes individual pre-class preparation using evidence-based learning materials, an Individual Readiness Assurance Test (I-RAT), a Team Readiness Assurance Test (T-RAT), team-based application activities focused on clinical decision-making, and structured feedback and debriefing facilitated by trained tutors. The Team-Based Learning session is delivered prior to the clinical simulation and is aligned with curricular objectives of undergraduate nursing education.
Active Comparator: Control; Traditional Clinical Simulation	Behavioral: Traditional Clinical Simulation; Participants receive standard clinical simulation activities as part of the undergraduate nursing curriculum. The simulation follows established educational practices routinely used in nursing education and does not include Team-Based Learning components such as readiness assurance tests, structured team application activities, or formal peer evaluation. Simulation content, learning objectives, duration, and assessment time points are aligned with those of the experimental group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Knowledge acquisition related to tracheobronchial suctioning	Level of theoretical knowledge related to tracheobronchial suctioning through a tracheostomy tube, including indications, procedural steps, safety aspects, and evidence-based recommendations. Knowledge is assessed using the Individual Readiness Assurance Test (I-RAT) consisting of 10 multiple-choice questions. Each correct answer is awarded 1 point, while incorrect answers receive 0 points. Total scores range from 0 to 10, with higher scores indicating greater knowledge.	Immediately post-intervention (T0), 3 months (T1), and 6 months (T2)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Technical skills performance in clinical simulation	Ability to correctly perform tracheobronchial suctioning through a tracheostomy tube in a simulated clinical setting. Technical skills are evaluated using a structured checklist based on the Objective Structured Clinical Examination (OSCE) model. The checklist includes 35 procedural steps, each scored 1 (correctly performed) or 0 (not performed or incorrectly performed). Total scores range from 0 to 35, with higher scores indicating better technical performance.	Immediately post-intervention (T0), 3 months (T1), and 6 months (T2)
Teamwork competencies	Self-reported teamwork competencies, including communication, coordination, problem-solving, and collaboration within a team. Competencies are measured using the validated Teamwork Competency Scale (TCS), consisting of 31 items rated on a 5-point Likert scale (1 = never, 5 = always). Total scores range from 31 to 155, with higher scores indicating better perceived teamwork competencies	Immediately post-intervention (T0), 3 months (T1), and 6 months (T2)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Attitude toward Team-Based Learning	Students' attitudes toward the Team-Based Learning methodology, including satisfaction, perceived usefulness, engagement, and contribution to learning. Attitudes are assessed using the Attitude Toward Team-Based Learning (ATL) questionnaire, consisting of 6 items rated on a 5-point Likert scale (1 = not at all; 5 = very much). Total scores range from 6 to 30, with higher scores indicating a more positive attitude toward Team-Based Learning.	Immediately post-intervention (T0), 3 months (T1), and 6 months (T2)

Collaborators and Investigators

• Sponsor: University of Pisa
• Investigators: Study Director: Nicola Pagnucci, RN, MSN, PhD, University of Pisa

Publications and helpful links

General Publications

• Koukourikos K, Tsaloglidou A, Kourkouta L, Papathanasiou IV, Iliadis C, Fratzana A, Panagiotou A. Simulation in Clinical Nursing Education. Acta Inform Med. 2021 Mar;29(1):15-20. doi: 10.5455/aim.2021.29.15-20.
• Alberti S, Motta P, Ferri P, Bonetti L. The effectiveness of team-based learning in nursing education: A systematic review. Nurse Educ Today. 2021 Feb;97:104721. doi: 10.1016/j.nedt.2020.104721. Epub 2020 Dec 11.
• Parmelee D, Michaelsen LK, Cook S, Hudes PD. Team-based learning: a practical guide: AMEE guide no. 65. Med Teach. 2012;34(5):e275-87. doi: 10.3109/0142159X.2012.651179. Epub 2012 Apr 4.

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2026
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): June 30, 2026

Study Registration Dates

• First Submitted: February 24, 2026
• First Submitted That Met QC Criteria: February 24, 2026
• First Posted (Actual): March 2, 2026

Study Record Updates

• Last Update Posted (Actual): March 17, 2026
• Last Update Submitted That Met QC Criteria: March 14, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Randomized controlled trial; Educational intervention; Nursing education; Clinical simulation; Active learning; Simulation-based education; Team-Based Learning; Undergraduate nursing students; Teamwork skills
• Other Study ID Numbers: TBLab-UNIPI-2026

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data will not be shared because the study involves undergraduate students and collects educational data that are anonymized and intended to be analyzed and reported only in aggregated form, in accordance with data protection regulations.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No